Aimmune Closes Enrolment in Phase III Peanut Allergy Study

Aimmune Therapeutics, Inc.AIMT announced that it has completed global enrollment in the phase III PALISADE study on AR101 for the desensitization of patients with peanut allergy.

Aimmune anticipates top-line data from the study in the fourth quarter of 2017. Positive data would allow the company to file regulatory applications for the candidate in both the U.S. and Europe in 2018. Notably, the company has completed North American enrollment in the PALISADE study this September.

Meanwhile, another study, RAMSES, which is scheduled to begin in the U.S. in early 2017, will evaluate AR101 in ‘real life’ clinical setting. Aimmune expects to submit a biologics license application (BLA) on the successful completion of the PALISADE and RAMSES studies.

Aimmune also announced the initiation of a randomized, double-blind, placebo-controlled, European study – ARTEMIS – evaluating AR101 in children and adolescents aged 4–17 years suffering from peanut allergy. Aimmune intends to enroll 120 to 160 patients in the study at multiple sites across Europe, beginning mid 2017. It expects to include data from the ARTEMIS study in its initial regulatory application in Europe.

We note that AR101 has received Breakthrough Therapy status from the FDA for the desensitization of patients aged 4–17 years with peanut allergy.

Note that post Trump’s victory in the Presidential race, shares of Aimmune have surged 15.7%, compared to a drop of 17.9% for the Zacks categorized Medical-Biomed/Genetics industry.

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Athersys’ loss estimates narrowed from 24 cents to 18 cents in 2016 and from 38 cents to 28 cents for 2017 over the last 60 days. The company posted a positive surprise in all of the four trailing quarters with an average beat of 110.52%. Its share price has gained 61% year to date.

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